Colombia Allows Faster Renewals for Lower-risk Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- Colombian regulator INVIMA is speeding up registration renewals for Class I and IIa medical devices.
- Registrants must still submit applications for renewal to INVIMA, but now will be granted those renewals within three days.
- The new INVIMA policy went into effect October 3, 2016.
Medical device market regulators in Colombia have begun allowing speedier renewals for licenses of lower-risk products.
As of October 3, 2016, Colombia’s medical device market regulator INVIMA implemented a new policy (link in Spanish) whereby registrants that submit applications for renewals to the institute will be granted such requests within three days of receipt rather than within one to two months, as is currently the case for registration renewals. The new policy pertains to Class I and IIa devices.